Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05620641

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the possible efficacy of ondansetron and gabapentin on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Nausea and Vomiting Sleeve Gastrectomy Morbid Obesity	Drug: Ondansetron 8mg Drug: Gabapentin	Phase 3

Detailed Description

This study will be a double blind randomized, controlled, parallel, study. A total of1 00 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into two groups by closed envelop method,

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 include 50 patients scheduled for sleeve gastrectomy	Drug: Ondansetron 8mg 50 patients will receive intravenous ondansetron 8 mg before the end of surgery. Other Names: zofran
Experimental: Group 2 include 50 patients scheduled for sleeve gastrectomy	Drug: Gabapentin 50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.

Arm

Intervention/Treatment

Experimental: Group 1

include 50 patients scheduled for sleeve gastrectomy

Drug: Ondansetron 8mg

50 patients will receive intravenous ondansetron 8 mg before the end of surgery.

Other Names:

zofran

Experimental: Group 2

include 50 patients scheduled for sleeve gastrectomy

Drug: Gabapentin

50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.

Outcome Measures

Primary Outcome Measures

The primary outcome of this study will be the complete response within the first 48 h after surgery. [The first 48 hours after surgery.]
Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy

Secondary Outcome Measures

change in the level of the biological parameter vasopressin [The first 48 hours after surgery.]
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of vasopressin
change in the level of the biological parameter dopamine [The first 48 hours after surgery.]
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of dopamine
change in the level of the biological parameter substance p [The first 48 hours after surgery.]
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of substance p
change in the level of the biological parameter Serotonin [The first 48 hours after surgery.]
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Serotonin
change in the level of the biological parameter Tachykinin 1 [The first 48 hours after surgery.]
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Tachykinin 1

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Both male and female patients will be included.
Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
Patients fit for anesthesia and surgery.

Exclusion Criteria:

- Patients with BMI >55 kg/m2.
Patients with previous procedures for the treatment of obesity.
Pregnant females and lactating women.
Patients with psychological or psychiatric disease
Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
Patients who experienced vomiting within 24 hours before surgery.
Patients with history of alcohol or drug abuse.
Patients with hypersensitivity or contraindications to any of the drugs used in this study.